Several studies have shown acceptable results after Pancreas Transplantation (PTx) by substituting ATG with basiliximab, which is considered to convey a considerably lower number of adverse events. However, our experiences with ATG in PTx (introduced in 2004) are good, and our presumably gentle way of administrating the drug - directed by T-cell counts - is in fact unique. The potential advantages of reducing the overall corticosteroid (CS) load is obvious, as CS is a well-known pro-diabetic agent and causes severe long term adverse effects.

On this background, the investigators have very recently reduced our CS dosing (in the routine protocol) to a level corresponding to our Kidney Tx protocol (valid since 2009).

Thus, the investigators intend to prospectively investigate a single PTx cohort with the reduced CS immunosuppressive protocol by an observational study design, and compare with previous (historical) cohorts, who have received high dose CS.

Study hypotheses: i) Low-dose CS is as effective as high-dose corticosteroids with regards to efficacy/rejections; ii) The rate of surgical and infectious complications will be similar or lower in the low-dose group; iii) PTx rejection surveillance by DD (duodenoduodeno-stomy) and EUSPB (Endoscopic Ultra-Sound guided Pancreas Biopsies) is superior to traditional rejection surveillance; iv) Patient and graft survival is similar in the two groups

Compare the incidence of acute rejection episodes at 6, 12, 36 and 60 months after pancreas transplantation, between our single prospective cohort with lower CS vs a historic, retrospective control group (PTx performed during 2011-2013). The incidence of rejection is defined as the fraction of patients in which rejections episodes (one or more) have been proven by biopsies. For SPK rejection in either organ, pancreas or kidney, counts.

Furthermore, we will compare the number and severity of rejection episodes in the pancreas allograft to the ones occurring in the kidney allograft (SPK), and the ones diagnosed by the duodenal segment biopsies.

Scheduled biopsies will be taken at 3 wks, 6 wks and 12 mts post-Tx; as well as indication biopsies, simultaneously from these four transplant/organ sources: Pancreas-Tx (P); Kidney-Tx (K); Duodenal segment of pancreas-Tx (tD); Native Duodenum (nD; serves as control)

The following analyses will be performed and correlated to rejection, functional parameters (glucose levels/need for insulin (P) and creatinine (K)), and graft survival. By daily blood samples during the first 10 days, 3 times a week until week 10, at 3 & 12 mts, and on indication.

This is a prospective, single cohort observational study, aimed at using a historical control group as comparison. It will be conducted at our single, national centre for organ transplantation in Oslo. All pancreas recipients > 18 years of age, who fulfill the inclusion criteria, will prior to transplantation be asked for inclusion.

This study will be conducted at our single, national centre for organ transplantation in Oslo.

All consecutive Pancreas-Tx recipients during 2-3 years are planned to be enrolled, with an intented number of 60-80 patients. The study will continue until all patients have completed a minimum of 60 months of follow-up or have discontinued participation in the study.

Criteria

Inclusion Criteria:

Age ≥18 years

Patients who receive a primary or secondary pancreas transplant, with or without a simultaneous kidney transplant (SPK).

Women who are of childbearing potential must have a negative serum pregnancy test at baseline.

Operability has to be ascertained by preoperative examination, performed by nephrologist, transplant surgeon and anaesthesiologist.

Signed and dated informed consent form.

Exclusion Criteria:

Evidence of systemic infection

Presence of unstable cardiovascular disease.

Malignancy < 5 years prior to entry into the trial (with the exception of adequately treated basal cell or squamous cell carcinomas of the skin).

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01957696